NCT00264979

Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

Detailed description

In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Conditions

• Colorectal Cancer
• Hepatic Metastases

Interventions

Type	Name	Description
PROCEDURE	Simultaneous surgery	Simultaneous surgery of colorectal cancer and synchronous liver metastases
PROCEDURE	Sequential surgery	Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.

Timeline

• Start date: 2006-03-02
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2005-12-13
• Last updated: 2019-03-11

Locations

14 sites across 1 country: France